Advanced Impella SmartAssist System for Subject Monitoring and Treatment: An Early Feasibility Study
Study of the Impella SmartAssist in Participants Undergoing High Risk Percutaneous Coronary Intervention (HRPCI)
Sponsor: Abiomed Inc.
Enrolling: Male and Female Patients
IRB Number: AAAT2216
U.S. Govt. ID: NCT04465201
Contact: Kate Dalton: 347-514-3366 /
Additional Study Information: The purpose of this study is to demonstrate that the Impella Hemodynamic Platform (the StudyDevice) is safe and that measurements obtained are as good as currently used methods. This includes how much pressure the heart is generating and how much blood your heart is pumping during the PCI. PCI is a surgical procedure that uses a catheter (a thin flexible tube) to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. The TheImpella device will be placed via the a femoral artery and delivers up to 3.5 liters of blood per minute to the heart. During its placement, the Impella CP with SmartAssist is positioned in such a way that will allow for the required measurements.
This study is closed
Jeffrey Moses, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
You may be eligible for this study

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For more information, please contact:
Kate Dalton